I cover cardiology news for CardioExchange, a social media website for cardiologists published by the New England Journal of Medicine. I was the editor of TheHeart.Org from its inception in 1999 until December 2008. Following the purchase of TheHeart.Org by WebMD in 2005, I became the editorial director of WebMD professional news, encompassing TheHeart.Org and Medscape Medical News. Prior to joining TheHeart.Org, I was a freelance medical journalist and wrote for a wide variety of medical and computer publications. In 1994-1995 I was a Knight Science Journalism Fellow at MIT. I have a PhD in English from SUNY Buffalo, and I drove a taxicab in New York City before embarking on a career in medical journalism. You can follow me on Twitter at: @cardiobrief.

Xarelto Effective In Medically Ill Patients But At High Bleeding Cost

The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the near future, as a new trial published in the New England Journal of Medicine shows that one of these novel drugs, though effective at preventing VTE, also resulted in a significant increase in bleeding risk.

In the Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Acutely Ill Medical Patients Comparing Rivaroxaban with Enoxaparin (MAGELLAN), first presented at the American College of Cardiology meeting in 2011, more than 8,000 medically ill patients were randomized to subcutaneous enoxaparin for 1o days or oral rivaroxaban (Xarelto, Johnson & Johnson) for 35 days.

In terms of efficacy, at 10 days rivaroxaban was found to be noninferior to enoxaparin and at 35 days was found to be superior to enoxparin (for 10 days) and placebo:

At 10 days the primary efficacy measure (a composite of asymptomatic proximal DVT, symptomatic DVT, symptomatic non-fatal PE, and VTE-related death) had occurred in 2.7% of patients in each group.

At 35 days a primary outcome event had occurred in 4.4% of patients in the rivaroxaban group compared with 5.7% in the enoxaparin and placebo group (RR 0.77, CI 0.62-0.96, p=0.02).

However, there were significantly more major or clinically relevant minor bleeding episodes in the rivaroxaban group at both day 10 and day 35:

At 10 days clinically relevant bleeding occurred in 2.8% of rivaroxaban patients versus 1.2% of patients in the enoxaparin group (RR=2.3, p< 0.001).

At 35 days, clinically relevant bleeding occurred in 4.1% of patients in the rivaroxaban group versus 1.7% of patients in the enoxaparin group (RR=2.5, p<0.001).

Rivaroxaban is currently indicated in the US for stroke reduction in patients with atrial fibrillation, for the treatment and prevention of recurrence of deep venous thrombosis and pulmonary embolism, and for DVT prophylaxis after orthopedic surgery. The FDA recently rejected the an indication for the use of rivaroxaban in patients with acute coronary syndrome.

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